Efficacy of Auricular Pressure Beans with Electroacupuncture and Estazolam Treating Insomnia Caused by Cancer

NCT06859190 | Recruiting Phase 3 DMC

• 1 other identifier: KY-2025-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The core objectives of this study are to assess the short-term and long-term efficacy of auricular acupoint pressure beans combined with electroacupuncture and estazolam in the treatment of cancer-caused insomnia. The study aims to accurately compare the differences between this combination therapy and standard Western medicine in improving sleep quality and effectively alleviating anxiety and depression. Additionally, it will meticulously observe the safety of the combined treatment and record the occurrence and potential causative factors of any adverse reactions.

Conditions

Cancer; Insomnia

Keywords

cancer; auricular pressure beans; electroacupuncture; insomnia; estazolam

Outcome Measures

Primary Outcomes (1)

• The Insomnia Severity Index(ISI)

  The scale is a simple tool used for screening insomnia, consisting of 7 items designed to assess the nature and symptoms of sleep disturbances in the subjects.

  Data will be collected at the end of the 0th, 4th, and 8th weeks of treatment and during follow-up (12th, 16th, and 20th weeks).

Secondary Outcomes (3)

• Pittsburgh Sleep Quality Index(PSQI)

  Data will be collected at the end of the 0th, 4th, and 8th weeks of treatment and during follow-up (12th, 16th, and 20th weeks).

• Hamilton Anxiety Scale(HAMA)

  Data will be collected at the end of the 0th, 4th, and 8th weeks of treatment and during follow-up (12th, 16th, and 20th weeks).

• Hamilton Depression Rating Scale(HAMD)

  Data will be collected at the end of the 0th, 4th, and 8th weeks of treatment and during follow-up (12th, 16th, and 20th weeks).

Study Arms (2)

Arm I (ONS group)

EXPERIMENTAL

Patients will receive estazolam with auricular pressure points and electroacupuncture treatment. Interventions:In the experimental group, estazolam (oral estazolam 1-2 mg daily at bedtime) was combined with auricular pressure point therapy and electroacupuncture over an 8-week period.

Drug: estazolam 1-2 mg; Procedure: Auricular pressure bean combined with electroacupuncture

Arm II (NS group)

ACTIVE COMPARATOR

Patients will follow the standard estazolam treatment program(oral estazolam 1-2 mg daily at bedtime for 8 weeks).

Drug: estazolam 1-2 mg

Interventions

estazolam 1-2 mg DRUG

oral estazolam 1-2 mg daily at bedtime for 8 weeks.

Arm I (ONS group); Arm II (NS group)

Auricular pressure bean combined with electroacupuncture PROCEDURE

Electroacupuncture treatment will be performed on seven acupoints, including Baihui (GV20), Shenting (GV24), Yintang (GV29), Anmian (EX-HN22), Shenmen (HT7), Neiguan (PC6), and Sanyinjiao (SP6). Each session lasts for 30 minutes and is conducted twice a week.In addition, auricular point seed-pressing therapy will be applied to bilateral auricular points related to insomnia (Shenmen, Heart, and Sympathetic). Each auricular point will be pressed for 1 minute, three times a day. The total treatment course is eight weeks.

Arm I (ONS group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and above.
• The diagnosis of a malignant solid tumor was confirmed by pathological examination.
• Clinically diagnosed cancer-caused insomnia with insomnia symptoms lasting more than 1 month, more than 3 or more times per week.
• An Insomnia Severity Index (ISI) score of 8 or higher and meets the criteria for insomnia disorder as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition.
• No medications related to the treatment of insomnia have been used in the last 1 month.
• No serious dysfunction of the heart, liver, kidneys or other vital organs.
• Patients volunteered to participate in this study and signed an informed consent form.

You may not qualify if:

• Irregular sleep-wake cycles in jobs with shift demands or due to inconsistent work schedules.
• Inadequately treated for another sleep disorder (e.g., sleep disorder disorders such as sleep apnea obstruction syndrome, restless leg syndrome, etc.).
• Received acupuncture or auricular pressure bean therapy within the past 3 months.
• Estimated life expectancy is ≥3 months.
• Have a history of severe allergies, especially to the drugs or treatments used in this study.
• History of severe mental illness with a current episode.
• History of substance abuse or alcohol dependence.

Sponsors & Collaborators

• Qinghai Red Cross Hospital: lead

Study Sites (1)

China, Qinghai,Qinghai Red Cross Hospital

Xining, Qinghai, 810000, China

RECRUITING

MeSH Terms

Conditions

Neoplasms; Sleep Initiation and Maintenance Disorders

Interventions

Estazolam; Electroacupuncture

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 5, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-02

Locations

CN (1)